Lead Engineer, Quality Validation

Job Description:
The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process.
Responsibilities:

• Provide quality oversight of Blue Mountain application for induction, calibration and maintenance of all lab equipment and instrumentation.
• Collaborate with lab systems owners on the induction and/or qualification activities of lab assets.
• dhere to regulatory guidance, policies, and procedures for qualification, and validation of Lab equipment and instrumentation.
• Use risk management principles for qualification and remediation efforts.
• Provide regular updates directly to Management.
• Perform other related duties as assigned.

Requirements:

• 8-12 years of relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred.
• Direct experience in qualification and validation using FDA, EMEA and ICH guidance required.
• Experience with qualifications of lab equipment and validation of processes associated to manufacture of clinical and commercial products highly desirable.
• Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally.
• Knowledge of biologics/gene therapy processes desirable.
• Prior QA experience highly desirable.
• ble to execute complex concepts, techniques, and standards and new applications based on quality principles and theories.
• ble to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Demonstrates knowledge of industry best practices and trends.
• Excellent verbal, written, and interpersonal communication skills are required.